RT Journal Article
SR Electronic
T1 Impact of macitentan on the health-related quality of life (HRQoL) in pulmonary arterial hypertension (PAH): Results from a long-term randomised controlled trial
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P4075
VO 42
IS Suppl 57
A1 Pavel Jansa
A1 Richard Channick
A1 Marion Delcroix
A1 Nazzareno Galiè
A1 Hossein-Ardeschir Ghofrani
A1 Elke Hunche
A1 Sanjay Mehta
A1 Camilla Mittelholzer
A1 Tomás Pulido
A1 B.K.S. Sastry
A1 Olivier Sitbon
A1 Rogério Souza
A1 Adam Torbicki
A1 Gérald Simonneau
A1 Lewis Rubin
YR 2013
UL http://erj.ersjournals.com/content/42/Suppl_57/P4075.abstract
AB The impact of macitentan, a novel endothelin receptor antagonist, on HRQoL was assessed in patients enrolled in the SERAPHIN study (randomised 1:1:1 to placebo, macitentan 3 or 10mg q.d.). Literate PAH patients (≥14 years), in WHO functional class II–IV, answered the Short Form 36-item (SF-36v2) at baseline, 6 and 12 months, and end-of-treatment (EOT). Placebo-corrected treatment effects for change from baseline to Month 6 and 12 are reported for the physical (PCS) and mental component summary (MCS) scores of the SF-36, with missing data imputed. Kaplan–Meier analyses of the time to a ≥5-point decrease (considered clinically relevant) from baseline in the PCS and MCS scores up to EOT were performed. Treatment groups were compared using log rank tests. Both doses of macitentan showed significant treatment effects vs placebo on the PCS and MCS at 6 and 12 months.View this table:Placebo-corrected treatment effect (mean [95% CI]) on PCS and MCS*Both doses reduced the risk of HRQoL deterioration, as measured by the time to ≥5-point decrease in the PCS (3mg: HR 0.70, 95%CI 0.54–0.92, P=0.008; 10mg: HR 0.65, 95%CI 0.50–0.85, P=0.001) and the MCS scores (3mg: HR 0.81, 95%CI 0.63–1.03, P=0.085; 10mg: HR 0.79, 95%CI 0.61–1.01, P=0.053) across the total study duration. In conclusion, macitentan improved HRQoL scores vs placebo and reduced the risk of decline in HRQoL over the duration of SERAPHIN.